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Conditional Approval

Meaning

Conditional Approval is a regulatory decision granted by health authorities, such as the European Medicines Agency (EMA) or the FDA under certain circumstances, that permits the early marketing of a medicinal product. This approval is contingent upon the applicant fulfilling specific obligations, typically involving the completion of ongoing studies or conducting new trials to confirm the drug’s benefits and safety profile. It is a mechanism used for medicines addressing unmet medical needs where the immediate public health benefit outweighs the risk of less comprehensive initial data.